- All > Medicine Access and Rational Use > Supply Management
- All > Quality and Safety: Medicines > Quality Assurance
- Keywords > diagnostic - methods
- Keywords > diagnostic tests
- Keywords > malaria
- Keywords > procurement
- Keywords > procurement - RDTs for malaria
- Keywords > product testing - malaria RDTs
- Keywords > quality assurance
- Keywords > quality control
- Keywords > quality control - lot testing
- Keywords > rapid diagnostic test (RDT)
(2011; 109 pages)
The aim of this manual is to provide guidance for the procurement of quality-assured malaria rapid diagnostic tests (RDTs) that reliably give accurate results. It is based on the results of WHO product testing of malaria RDTs and on WHO-recommended criteria for procuring RDTs. The guidance provided is general and should be adapted to the local context.
The target audience for this manual includes procurement officers, malaria programme managers, health officers and supply chain managers responsible for selecting, procuring or assisting in the procurement of RDTs for malaria in the public and private sectors.
The manual summarizes information from publications on the quality of malaria RDTs that is readily accessible only by specialized procurement agencies. Its aim is to improve understanding of the following aspects of procurement:
- performance components and selection criteria,
- estimating quantity requirements and budgeting,
- defining technical specifications,
- managing tenders, adjudications and contracts,
- quality control through lot testing,
- supply management and product recalls, and
- monitoring supplier performance and managing product variations.
This manual covers activities in the procurement cycle up to the receipt of goods at the port of entry. It does not cover in-country storage, transport or distribution, as these are covered in other manuals. It describes good procurement practice in a non-prescriptive manner, providing checklists and covering technical issues...
(Microscopy and RDT s are both adequate to diagnose malaria in febrile patients. Demonstration of the presence of malaria parasites is advised before treatment with antimalarial medicines, as diagnosis based solely on clinical symptoms is of poor accuracy and leads to overdiagnosis of malaria, waste of antimalarial medicines, an increased frequency of adverse side-effects and increased drug pressure on resistant parasites. Early exclusion of malaria can enhance early diagnosis and appropriate management of other, potentially severe causes of fever. Parasitological diagnosis improves malaria case detection and surveillance systems.)